Trial Outcomes & Findings for Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease. (NCT NCT04704531)
NCT ID: NCT04704531
Last Updated: 2026-03-03
Results Overview
OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Group 1
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop twice a day (BID) in both eyes (OU) during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop four time a days (QID) in both eyes (OU) during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop six times per day in both eyes (OU) during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
47
|
|
Overall Study
COMPLETED
|
45
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=47 Participants
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=47 Participants
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=47 Participants
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=47 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=141 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=47 Participants
|
45 Participants
n=47 Participants
|
44 Participants
n=47 Participants
|
134 Participants
n=141 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=47 Participants
|
2 Participants
n=47 Participants
|
3 Participants
n=47 Participants
|
7 Participants
n=141 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 14.6 • n=47 Participants
|
38.9 years
STANDARD_DEVIATION 13.3 • n=47 Participants
|
36.5 years
STANDARD_DEVIATION 14.9 • n=47 Participants
|
37.95 years
STANDARD_DEVIATION 14.21 • n=141 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=47 Participants
|
31 Participants
n=47 Participants
|
28 Participants
n=47 Participants
|
91 Participants
n=141 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=47 Participants
|
16 Participants
n=47 Participants
|
19 Participants
n=47 Participants
|
50 Participants
n=141 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
47 participants
n=47 Participants
|
47 participants
n=47 Participants
|
47 participants
n=47 Participants
|
141 participants
n=141 Participants
|
|
Brake up time of the tear film
|
9.1 seconds
STANDARD_DEVIATION 3.3 • n=47 Participants
|
9.0 seconds
STANDARD_DEVIATION 2.5 • n=47 Participants
|
9.2 seconds
STANDARD_DEVIATION 2.8 • n=47 Participants
|
9.0 seconds
STANDARD_DEVIATION 3.5 • n=141 Participants
|
PRIMARY outcome
Timeframe: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).Population: The evaluated population for this outcome measure was the population per protrocol (PP) (subjects who finished the study without presenting any mayor deviations to protocol)
OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.
Outcome measures
| Measure |
Group 1
n=45 Participants
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Participants
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Participants
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Ocular Surface Disease Index (OSDI)
BV
|
25.8 score on a scale
Standard Deviation 4.9
|
25.8 score on a scale
Standard Deviation 4.7
|
24.8 score on a scale
Standard Deviation 5.3
|
|
Change in Ocular Surface Disease Index (OSDI)
FV
|
12.8 score on a scale
Standard Deviation 6.0
|
12.2 score on a scale
Standard Deviation 5.8
|
11.9 score on a scale
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Up to Day 33 (+ 1) (safety call).Population: This outcome measure considered the Safety Population (SP), all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution and whether it was considered related or not to the investigation products.
Outcome measures
| Measure |
Group 1
n=94 Eyes
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=94 Eyes
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=94 Eyes
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Incidence of Adverse Events (AE)
Related and expected AE
|
11 adverse events
|
9 adverse events
|
7 adverse events
|
|
Incidence of Adverse Events (AE)
Related and unexpected AE
|
24 adverse events
|
17 adverse events
|
22 adverse events
|
|
Incidence of Adverse Events (AE)
Non-related AE
|
21 adverse events
|
15 adverse events
|
16 adverse events
|
SECONDARY outcome
Timeframe: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
After application of fluorescein stain, using a slit lamp and its cobalt blue filter, the time elapsed after instructing the patient to blink 1 or 2 times and the appearance of dry spots on the ocular surface will be counted and reported as BUT. Normally, this parameter is ≥ 10 seconds.
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Tear Break-up Time (BUT)
BV
|
6.1 seconds
Standard Deviation 2.2
|
6.4 seconds
Standard Deviation 2.1
|
6.3 seconds
Standard Deviation 2.3
|
|
Change in Tear Break-up Time (BUT)
V1
|
9.1 seconds
Standard Deviation 3.3
|
9.0 seconds
Standard Deviation 2.5
|
9.2 seconds
Standard Deviation 2.8
|
|
Change in Tear Break-up Time (BUT)
FV
|
9.7 seconds
Standard Deviation 3.4
|
10.1 seconds
Standard Deviation 3.2
|
11.0 seconds
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
BV Conjunctival and corneal staining with lissamine green : Minimal(I)
|
21 Eyes (right)
|
19 Eyes (right)
|
21 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
BV Conjunctival and corneal staining with lissamine green : Absent (0)
|
15 Eyes (right)
|
15 Eyes (right)
|
14 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
BV Conjunctival and corneal staining with lissamine green : Mild (II)
|
9 Eyes (right)
|
10 Eyes (right)
|
10 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
BV Conjunctival and corneal staining with lissamine green : Moderate (III)
|
0 Eyes (right)
|
1 Eyes (right)
|
1 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
V1 Conjunctival and corneal staining with lissamine : Absent (0)
|
28 Eyes (right)
|
30 Eyes (right)
|
31 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
V1 Conjunctival and corneal staining with lissamine : Minimal(I)
|
15 Eyes (right)
|
14 Eyes (right)
|
15 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
V1 Conjunctival and corneal staining with lissamine : Mild (II)
|
2 Eyes (right)
|
1 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
V1 Conjunctival and corneal staining with lissamine : Moderate (III)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
FV Conjunctival and corneal staining with lissamine : Absent (0)
|
40 Eyes (right)
|
36 Eyes (right)
|
43 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
FV Conjunctival and corneal staining with lissamine : Minimal(I)
|
5 Eyes (right)
|
9 Eyes (right)
|
3 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
FV Conjunctival and corneal staining with lissamine : Mild (II)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Lissamine Green
FV Conjunctival and corneal staining with lissamine : Moderate (III)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
SECONDARY outcome
Timeframe: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
The evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Conjunctival and Corneal Staining With Fluorescein
BV Conjunctival and corneal staining with fluorescein : Absent (0)
|
13 Eyes (right)
|
11 Eyes (right)
|
11 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
BV Conjunctival and corneal staining with fluorescein : Minimal (I)
|
20 Eyes (right)
|
22 Eyes (right)
|
25 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
BV Conjunctival and corneal staining with fluorescein : Mild (II)
|
12 Eyes (right)
|
11 Eyes (right)
|
9 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
BV Conjunctival and corneal staining with fluorescein : Moderate (III)
|
0 Eyes (right)
|
1 Eyes (right)
|
1 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
V1 Conjunctival and corneal staining with fluorescein : Absent (0)
|
20 Eyes (right)
|
23 Eyes (right)
|
28 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
V1 Conjunctival and corneal staining with fluorescein : Minimal (I)
|
19 Eyes (right)
|
21 Eyes (right)
|
17 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
V1 Conjunctival and corneal staining with fluorescein : Mild (II)
|
6 Eyes (right)
|
1 Eyes (right)
|
1 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
V1 Conjunctival and corneal staining with fluorescein : Moderate (III)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
FV Conjunctival and corneal staining with fluorescein : Absent (0)
|
28 Eyes (right)
|
30 Eyes (right)
|
36 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
FV Conjunctival and corneal staining with fluorescein : Minimal (I)
|
16 Eyes (right)
|
15 Eyes (right)
|
10 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
FV Conjunctival and corneal staining with fluorescein : Mild (II)
|
1 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival and Corneal Staining With Fluorescein
FV Conjunctival and corneal staining with fluorescein : Moderate (III)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
SECONDARY outcome
Timeframe: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (III), and Severe (IV).
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Conjunctival Hyperemia
FV: Normal (0)
|
20 Eyes (right)
|
21 Eyes (right)
|
24 Eyes (right)
|
|
Change in Conjunctival Hyperemia
FV: Very Mild (I)
|
24 Eyes (right)
|
24 Eyes (right)
|
21 Eyes (right)
|
|
Change in Conjunctival Hyperemia
FV: Mild (II)
|
1 Eyes (right)
|
0 Eyes (right)
|
1 Eyes (right)
|
|
Change in Conjunctival Hyperemia
FV: Moderate (III)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival Hyperemia
V1: Very Mild (I)
|
21 Eyes (right)
|
23 Eyes (right)
|
28 Eyes (right)
|
|
Change in Conjunctival Hyperemia
V1: Mild (II)
|
8 Eyes (right)
|
4 Eyes (right)
|
4 Eyes (right)
|
|
Change in Conjunctival Hyperemia
V1: Moderate (III)
|
0 Eyes (right)
|
0 Eyes (right)
|
0 Eyes (right)
|
|
Change in Conjunctival Hyperemia
V1: Normal (0)
|
16 Eyes (right)
|
18 Eyes (right)
|
14 Eyes (right)
|
|
Change in Conjunctival Hyperemia
BV: Normal (0)
|
11 Eyes (right)
|
6 Eyes (right)
|
7 Eyes (right)
|
|
Change in Conjunctival Hyperemia
BV: Very Mild (I)
|
14 Eyes (right)
|
21 Eyes (right)
|
19 Eyes (right)
|
|
Change in Conjunctival Hyperemia
BV: Mild (II)
|
17 Eyes (right)
|
17 Eyes (right)
|
19 Eyes (right)
|
|
Change in Conjunctival Hyperemia
BV: Moderate (III)
|
3 Eyes (right)
|
1 Eyes (right)
|
1 Eyes (right)
|
SECONDARY outcome
Timeframe: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent. This evaluation will be made taking in consideration the counts of "absent" seen per counts of eyes and per visit.
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Incidence of Chemosis
BV: Absent
|
45 Eyes (right)
|
45 Eyes (right)
|
46 Eyes (right)
|
|
Incidence of Chemosis
V1: Absent
|
45 Eyes (right)
|
45 Eyes (right)
|
46 Eyes (right)
|
|
Incidence of Chemosis
FV: Absent
|
45 Eyes (right)
|
45 Eyes (right)
|
46 Eyes (right)
|
SECONDARY outcome
Timeframe: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc. The normal score for a VA is 20/20.This score is expressed in decimal (i.e. 1.0) format. In decimal format, a lower number is a worse outcome.
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA)
BV
|
0.97 decimal score
Standard Deviation 0.08
|
0.99 decimal score
Standard Deviation 0.04
|
0.98 decimal score
Standard Deviation 0.04
|
|
Change in Best Corrected Visual Acuity (BCVA)
V1
|
0.98 decimal score
Standard Deviation 0.07
|
0.99 decimal score
Standard Deviation 0.02
|
0.99 decimal score
Standard Deviation 0.02
|
|
Change in Best Corrected Visual Acuity (BCVA)
FV
|
0.97 decimal score
Standard Deviation 0.08
|
0.99 decimal score
Standard Deviation 0.03
|
0.99 decimal score
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable.
Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP will be evaluated. Normal values are considered between 10 and 21 mmHg.
Outcome measures
| Measure |
Group 1
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=45 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=46 Eyes (right)
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Change in Intraocular Pressure (IOP)
FV
|
13.6 mmHg
Standard Deviation 2.5
|
13.8 mmHg
Standard Deviation 2.2
|
13.7 mmHg
Standard Deviation 2.1
|
|
Change in Intraocular Pressure (IOP)
BV
|
13.7 mmHg
Standard Deviation 2.6
|
14.5 mmHg
Standard Deviation 2.8
|
14.4 mmHg
Standard Deviation 2.5
|
|
Change in Intraocular Pressure (IOP)
V1
|
13.6 mmHg
Standard Deviation 2.4
|
14.1 mmHg
Standard Deviation 2.3
|
13.6 mmHg
Standard Deviation 2.1
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=47 participants at risk
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=47 participants at risk
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=47 participants at risk
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Immune system disorders
reaction to immunization
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
Other adverse events
| Measure |
Group 1
n=47 participants at risk
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
|
Group 2
n=47 participants at risk
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
|
Group 3
n=47 participants at risk
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Pain in area of administration
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular Pain
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like illness
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Nervous system disorders
Hypoesthesia
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular irritation
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
General disorders
Sticky Skin
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Abormal ocular sensation
|
12.8%
6/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
6.4%
3/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular hyperaemia
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Foreign body sensation in the eye
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
6.4%
3/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Asthenopia
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Blurred vision
|
10.6%
5/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Stye eye (hordeolum)
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Tearing
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
conjunctivitis
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
photophobia
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
abnormal sensation in the eye
|
12.8%
6/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
6.4%
3/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Endocrine disorders
dysmenorrhea
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
diplopia
|
2.1%
1/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Product Issues
presence of product residue
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
10.6%
5/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.5%
4/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Irritation in the area of instillation
|
31.9%
15/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
29.8%
14/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
27.7%
13/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Pruritus
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
10.6%
5/47 • From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (CRF) where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place